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NCT06055075 · REGISTRY CONDITION SEARCH

A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
TERMINATED
Registry last update
2026-09-29

The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of forimtamig when administered alone or in combination with carfilzomib or daratumumab or other combination partners in participants with relapsed or refractory multiple myeloma (r/r MM). The study consists of two phases: a dose exploration phase and a dose-expansion phase.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Adverse Effects (AEs)

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outcome · POSTED

Number of Participants With Cytokine Release Syndrome (CRS), With Severity Determined According to American Society of Transplantation and Cellular Therapy (ASTCT) Consensus Grading

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outcome · POSTED

Number of Participants With Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), With Severity Determined According to ASTCT Consensus Grading

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outcome · POSTED

Investigator-assessed Objective Response Rate (ORR) Per International Myeloma Working Group (IMWG) Response Criteria

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outcome · POSTED

Investigator-assessed Complete Response Rate (CRR) / Stringent Complete Response Rate (sCRR) Per IMWG Response Criteria

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outcome · POSTED

Investigator-assessed VGPR Rate or Better Per IMWG Response Criteria

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outcome · POSTED

Investigator-assessed Progression-free Survival (PFS) Per IMWG Response Criteria

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outcome · POSTED

Investigator-assessed Duration of Response (DoR) for Participants Who Achieved PR or Better

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outcome · POSTED

Investigator-assessed Time to Response (TTR) Per IMWG Response Criteria

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outcome · POSTED

Investigator-assessed Time to Best Response (TTBR) Per IMWG Response Criteria

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outcome · POSTED

Investigator-assessed Overall Survival (OS)

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outcome · POSTED

Number of Participants With Anti-drug Antibodies (ADAs) to Forimtamig

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outcome · POSTED

Serum Concentrations of Forimtamig at the Specified Timepoints

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outcome · POSTED

Area Under the Concentration-time Curve From Dosing to the Time of the Last Measured Concentration (AUClast) of Forimtamig

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outcome · POSTED

Maximum Observed Concentration (Cmax) of Forimtamig

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Life expectancy of at least 12 weeks * Documented diagnosis of MM according to the IMWG diagnostic criteria * Evidence of progressive disease based on Investigator's determination of response by IMWG criteria on or after last dosing regimen * Measurable disease * AEs from prior anti-cancer therapy resolved to Grade ≤ 1, * Adequate organ functions Exclusion Criteria: * Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the last dose of study drug * Plasma cell leukemia with circulating plasma cell count ≥ 5% or \>500/microliter (µL) * Participants with known amyloidosis * Participants with myelodysplastic syndrome * Prior treatment with monoclonal antibody (mAb) and antibody-drug conjugate within 4 weeks or 5 half-lives of the drug, whichever is shorter * Prior anti-cancer therapy (chemotherapy, small molecule/tyrosine kinase inhibitors, radiotherapy) within 14 days prior to first forimtamig administration * Prior solid organ transplantation * Active auto-immune disease or flare within 6 months prior to start of study treatment * Known or suspected chronic active Epstein-Barr virus (EBV) infection * Hepatitis B virus (HBV) infection * Acute or chronic hepatitis C virus (HCV) infection * Known history of HIV seropositivity * Live vaccine(s) within one month prior to start of the treatment * Participants not fully vaccinated for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as per local recommendations * Previous refractoriness to carfilzomib * Participants who discontinued prior carfilzomib treatment due to treatment-related toxicity * Participants with known liver cirrhosis * Participants eligible for allogeneic stem cell transplantation (SCT) or autologous SCT at the time of enrollment for Study BP43437 are excluded
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants will receive Dose 1 of forimtamig, subcutaneous (SC) injection in combination with carfilzomib, intravenous (IV) infusion until disease progression.
    intervention Names
    1. Drug: Forimtamig
    2. Drug: Carfilzomib
    label
    Dose Exploration Phase: Forimtamig (Dose 1) + Carfilzomib
    type
    EXPERIMENTAL
  2. description
    Participants will receive Dose 2 of forimtamig, SC injection in combination with carfilzomib, IV infusion until disease progression.
    intervention Names
    1. Drug: Forimtamig
    2. Drug: Carfilzomib
    label
    Dose Exploration Phase: Forimtamig (Dose 2) + Carfilzomib
    type
    EXPERIMENTAL
  3. description
    Participants will receive Dose 3 of forimtamig, SC injection in combination with carfilzomib, IV infusion until disease progression.
    intervention Names
    1. Drug: Forimtamig
    2. Drug: Carfilzomib
    label
    Dose Exploration Phase: Forimtamig (Dose 3) + Carfilzomib
    type
    EXPERIMENTAL
  4. description
    Participants will receive Dose 1 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression.
    intervention Names
    1. Drug: Forimtamig
    2. Drug: Daratumumab
    label
    Dose Exploration Phase: Forimtamig (Dose 1) + Daratumumab
    type
    EXPERIMENTAL
  5. description
    Participants will receive Dose 2 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression.
    intervention Names
    1. Drug: Forimtamig
    2. Drug: Daratumumab
    label
    Dose Exploration Phase: Forimtamig (Dose 2) + Daratumumab
    type
    EXPERIMENTAL
  6. description
    Participants will receive Dose 3 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression.
    intervention Names
    1. Drug: Forimtamig
    2. Drug: Daratumumab
    label
    Dose Exploration Phase: Forimtamig (Dose 3) + Daratumumab
    type
    EXPERIMENTAL
  7. description
    Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase until disease progression or completion of 12 months of treatment, whichever occurs first.
    intervention Names
    1. Drug: Forimtamig
    label
    Dose Expansion Phase: Forimtamig
    type
    EXPERIMENTAL
  8. description
    Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase in combination with carfilzomib, IV infusion until disease progression.
    intervention Names
    1. Drug: Forimtamig
    2. Drug: Carfilzomib
    label
    Dose Expansion Phase: Forimtamig + Carfilzomib
    type
    EXPERIMENTAL
  9. description
    Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase in combination with daratumumab, SC injection until disease progression.
    intervention Names
    1. Drug: Forimtamig
    2. Drug: Daratumumab
    label
    Dose Expansion Phase: Forimtamig + Daratumumab
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Dose Expansion Phase: Forimtamig
    2. Dose Expansion Phase: Forimtamig + Carfilzomib
    3. Dose Expansion Phase: Forimtamig + Daratumumab
    4. Dose Exploration Phase: Forimtamig (Dose 1) + Carfilzomib
    5. Dose Exploration Phase: Forimtamig (Dose 1) + Daratumumab
    6. Dose Exploration Phase: Forimtamig (Dose 2) + Carfilzomib
    7. Dose Exploration Phase: Forimtamig (Dose 2) + Daratumumab
    8. Dose Exploration Phase: Forimtamig (Dose 3) + Carfilzomib
    9. Dose Exploration Phase: Forimtamig (Dose 3) + Daratumumab
    description
    Forimtamig will be administered SC at different doses during dose exploration phase. Forimtamig will be administered at a fixed dose determined during dose exploration phase in dose expansion phase.
    name
    Forimtamig
    type
    DRUG
  2. arm Group Labels
    1. Dose Expansion Phase: Forimtamig + Carfilzomib
    2. Dose Exploration Phase: Forimtamig (Dose 1) + Carfilzomib
    3. Dose Exploration Phase: Forimtamig (Dose 2) + Carfilzomib
    4. Dose Exploration Phase: Forimtamig (Dose 3) + Carfilzomib
    description
    Carfilzomib will be administered via IV infusion in combination with forimtamig.
    name
    Carfilzomib
    type
    DRUG
  3. arm Group Labels
    1. Dose Expansion Phase: Forimtamig + Daratumumab
    2. Dose Exploration Phase: Forimtamig (Dose 1) + Daratumumab
    3. Dose Exploration Phase: Forimtamig (Dose 2) + Daratumumab
    4. Dose Exploration Phase: Forimtamig (Dose 3) + Daratumumab
    description
    Daratumumab will be administered via SC injection in combination with forimtamig.
    name
    Daratumumab
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
SEQUENTIAL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
21
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
    measure
    Number of Participants With Adverse Effects (AEs)
    time Frame
    From initiation of study treatment up to approximately 15.7 months
  2. description
    CRS=supraphysiologic response following administration of any immune therapy that results in activation/engagement of endogenous or infused T cells and/or other immune effector cells. Symptoms may be progressive, including fever at onset, headache, and myalgia and may also include hypotension, capillary leak (hypoxia), dyspnea, chest discomfort and end-organ dysfunction. Severity of CRS was determined per ASTCT Consensus Grading Criteria, which categorizes CRS into 5 grades- Grade 1: Fever (≥38◦Celsius), with/without constitutional symptoms, in absence of hypotension \& hypoxia; Grade 2: Fever with hypotension not requiring vasopressors and/or hypoxia requiring low-flow oxygen; Grade 3: Fever with hypotension requiring one vasopressor, with/without vasopressin, and/or hypoxia requiring high-flow oxygen; Grade 4: Fever accompanied by hypotension requiring multiple vasopressors (excluding vasopressin) and/or hypoxia requiring positive-pressure ventilation; Grade 5: death due to CRS.
    measure
    Number of Participants With Cytokine Release Syndrome (CRS), With Severity Determined According to American Society of Transplantation and Cellular Therapy (ASTCT) Consensus Grading
    time Frame
    From initiation of study treatment up to approximately 15.7 months
  3. description
    ICANS grade is determined by the most severe event (immune effector cell-associated encephalopathy \[ICE\] score, level of consciousness, seizures, motor findings, raised intracranial pressure \[ICP\]/cerebral edema) not attributed to any other cause. Grade 1=ICE score of 7-9; awakens spontaneously; no seizure/motor findings/elevated ICP/cerebral edema. Grade 2=ICE score of 3-6; awakes voice; no seizure/motor findings/elevated ICP/cerebral edema. Grade 3=ICE score of 0-2; awakes only to tactile stimulus; any clinical seizure focal or generalized that resolves rapidly or nonconvulsive seizure on EEG that resolves with intervention; no motor findings; focal/local edema on neuroimaging.
    measure
    Number of Participants With Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), With Severity Determined According to ASTCT Consensus Grading
    time Frame
    From initiation of study treatment up to approximately 15.7 months
  4. description
    ORR=percentage of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) per IMWG response criteria. CR \& sCR are defined as outlined in endpoint 5 (CRR/sCRR). VGPR=serum \& urine M-protein (UMP) detectable by immunofixation, but not electrophoresis; ≥90% reduction in serum M-protein (SMP) + UMP level \<100 mg/24 hrs; at baseline ≥90% reduction in sum of the maximal perpendicular diameter (SPD) compared with baseline for soft tissue plasmacytoma \& ≥90% decrease in the difference between involved \& uninvolved SFLC levels. PR=≥50% reduction in SMP \& UMP reduction ≥90% or \<200 mg/24hours; if SMP \& UMP not measurable, ≥50% decrease in involved \& uninvolved SFLC difference in place of M-protein criteria; if SMP, UMP \& SFLC assay not unmeasurable, ≥50% reduction in plasma cells required in place of M-protein (baseline BM plasma cell ≥30%); at baseline, a ≥50% reduction in SPD of soft tissue plasmacytomas.
    measure
    Investigator-assessed Objective Response Rate (ORR) Per International Myeloma Working Group (IMWG) Response Criteria
    time Frame
    Up to approximately 15.2 months
  5. description
    CRR and sCRR were defined as the percentage of participants with CR or sCR, as determined by the investigator per IMWG response criteria. CR was defined as: no evidence of initial monoclonal protein isotype(s) on immunofixation of the serum \& urine; Disappearance of any soft tissue plasmacytomas; \<5% plasma cells in BM \& a normal SFLC ratio of 0.26-1.65. sCR was defined as: CR (defined above); normal SFLC ratio, \& absence of clonal cells in BM by IHC or negative by 2-4 color flow cytometry. CR and sCR are distinct response categories and are evaluated and reported separately in accordance with the defined response criteria i.e., if a response is clinically upgraded from CR to sCR it is not further considered a CR but solely a sCR. Percentages have been rounded off.
    measure
    Investigator-assessed Complete Response Rate (CRR) / Stringent Complete Response Rate (sCRR) Per IMWG Response Criteria
    time Frame
    Up to approximately 15.2 months
  6. description
    VGPR rate was defined as the percentage of participants with VGPR as determined by the investigator per IMWG response criteria. VGPR was defined as: serum \& UMP detectable by immunofixation, but not on electrophoresis; or ≥90% reduction in SMP plus UMP level \<100 mg/24 hours; at baseline ≥90% reduction in SPD compared with baseline for soft tissue plasmacytoma \& ≥90% decrease in the difference between involved \& uninvolved SFLC levels. Responses better than VGPR include CR and sCR (as defined in endpoint 5). Percentages have been rounded off.
    measure
    Investigator-assessed VGPR Rate or Better Per IMWG Response Criteria
    time Frame
    Up to approximately 15.2 months
secondary Outcomes
  1. description
    PFS=time from randomization until disease progression (PD) per IMWG criteria or death from any cause. PD=any 1 or more of the following: Increase of 25% from lowest response value in any of the following: Serum M-component, Urine M-component or in participants without measurable SMP \& UMP levels: difference between involved \& uninvolved FLC levels; For non-secretory participants at study entry: in participants without measurable SMP \& UMP levels \& without measurable disease by FLC: BM plasma cell percentage irrespective of baseline status (absolute %must be ≥10%); appearance of a new lesion/s, ≥ 50% increase from nadir in SPD of \>1 lesion, or ≥50% increase in the longest diameter of a previous lesion \>1centimeters (cm) in short axis; Definite development of new bone lesions/definite increase in the size of existing bone lesions; ≥50% increase in circulating plasma cells. Kaplan-Meier (K-M) method was used to estimate the median PFS. Overall number analyzed=participants with an event.
    measure
    Investigator-assessed Progression-free Survival (PFS) Per IMWG Response Criteria
    time Frame
    Up to approximately 15.2 months
  2. description
    DoR was defined as the time from the initial objective response (OR) (sCR, CR, PR, or VGPR) to the time of PD or death from any cause as determined by the investigator per IMWG response criteria. CR, sCR, VGPR, and PR were defined the same as outlined in the description for the primary endpoint ORR. PD was defined as outlined in the description for the endpoint PFS. K-M method was used to estimate the median DOR.
    measure
    Investigator-assessed Duration of Response (DoR) for Participants Who Achieved PR or Better
    time Frame
    Up to approximately 15.2 months
  3. description
    TTR was defined as the time from randomization until an OR (PR or better), as determined by the investigator per IMWG response criteria. CR, sCR, VGPR and PR were defined the same as outlined in the description for the primary endpoint ORR. K-M method was used to estimate the median TTR.
    measure
    Investigator-assessed Time to Response (TTR) Per IMWG Response Criteria
    time Frame
    Up to approximately 15.2 months
  4. description
    TTBR was defined as the time from randomization until the best OR (sCR, CR, VGPR, or PR), as determined by the investigator per IMWG response criteria. CR, sCR, VGPR and PR were defined the same as outlined in the description for the primary endpoint ORR. K-M method was used to estimate the median TTBR.
    measure
    Investigator-assessed Time to Best Response (TTBR) Per IMWG Response Criteria
    time Frame
    Up to approximately 15.2 months
  5. description
    OS was defined as the time from randomization to death from any cause as determined by the investigator per IMWG response criteria. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. K-M method was used to estimate the median OS.
    measure
    Investigator-assessed Overall Survival (OS)
    time Frame
    Up to approximately 15.7 months
  6. description
    Participants who received forimtamig were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following forimtamig exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants with a positive post-baseline sample have been reported here.
    measure
    Number of Participants With Anti-drug Antibodies (ADAs) to Forimtamig
    time Frame
    Up to approximately 15.7 months
  7. measure
    Serum Concentrations of Forimtamig at the Specified Timepoints
    time Frame
    Pre-dose on Day (D)1 of Cycle (C)1,2&4, D4 of C1&5, D2C3; 4hours post-dose on D1,4 of C1, D2C3, D1C4, D4C5; D2,8,9,11,15,16&18 of C1; D2,8,15,22 of C2&4; D1,4,8,15,22 of C3; D1,8,15 of C5; D1,4,8,15 of C6,7,8&9; D1,4,8 of C10
  8. measure
    Area Under the Concentration-time Curve From Dosing to the Time of the Last Measured Concentration (AUClast) of Forimtamig
    time Frame
    Up to Day 15 of Cycle 3 (1 cycle=28 days)
  9. measure
    Maximum Observed Concentration (Cmax) of Forimtamig
    time Frame
    Day 1 of Cycle 3 (1 cycle=28 days)
Full study description
brief Summary
The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of forimtamig when administered alone or in combination with carfilzomib or daratumumab or other combination partners in participants with relapsed or refractory multiple myeloma (r/r MM). The study consists of two phases: a dose exploration phase and a dose-expansion phase.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice